The following data is part of a premarket notification filed by Becton Dickinson Microbiology Systems with the FDA for Gc Ii Agar With Isovitalex.
| Device ID | K932882 |
| 510k Number | K932882 |
| Device Name: | GC II AGAR WITH ISOVITALEX |
| Classification | Culture Media, Antimicrobial Susceptibility Test, Excluding Mueller Hinton Agar |
| Applicant | BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Contact | Robert E James |
| Correspondent | Robert E James BECTON DICKINSON MICROBIOLOGY SYSTEMS P.O. BOX 243 Cockeysville, MD 21030 -0243 |
| Product Code | JSO |
| CFR Regulation Number | 866.1700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1993-09-24 |